Eli Lilly Announces Worldwide Xigris Recall

Eli Lilly has decided to issue a worldwide market withdrawal of Xigris, a drug used to treat sepsis, after a clincial trial failed to show any survival benefit for patients with severe sepsis and septic shock treated with the medication. According to a notice from the U.S. Food & Drug Administration (FDA), Xigris treatment should not be started in any new patients, while patients currently being treated with the drug should have the treatment terminated. All remaining Xigris product should be returned to the supplier from whom it was purchased.

Xigris is used solely in hospital intensive care units to treat patients at a high risk of death due to serious complications of sepsis and septic shock. Sepsis is a serious medical condition involving infection and generalized inflammation, and can result in damage to vital body organs, leading to bleeding, organ failure and, in many cases, death.

According to the FDA, in the PROWESS-SHOCK trial, Xigris failed to show a survival benefit. The clinical trial, which started in 2008, included 1696 patients, 851 treated with Xigris arm and 845 patients treated with placebo. Results based on preliminary analyses done by Eli Lilly that were submitted to the FDA showed a 28-day all cause mortality rate of 26.4% (223/846) in Xigris-treated patients compared to 24.2% in placebo-treated patients.

According to a Reuters report, while Xigris had been associated with a risk of serious bleeding in earlier studies, no significant higher risk was found in the PROWESS-SHOCK trial.

According to a report from IndyStar.com, Eli Lilly spent hundreds of millions of dollars to develop Xigris, but during its quest for approval a decade ago, failed to get a clear endorsement from an FDA review panel. Some on the panel questioned the way some of the drug’s clinical trials where handled, and only half of the advisors on the 20-member panel voted in favor of approval.

Lilly hoped the drug would generate annual sales of more than $1 billion, IndyStar.com said, but last year Xigris only generated worldwide sales of $104 million.